Events

Retiro De Equipo (Recall) de HeartWare Ventricular Assist Device (HVAD) System HeartWare HVAD Pump Implant Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Heartware Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01090-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-08-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01090-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Heartware have identified that specified implant kit pumps may be more susceptible to electrical faults (and connection failures) if the driveline that connects the pump to the controller becomes contaminated. contamination can occur during the implant procedure or post operatively from fluid ingress into the driveline, and occurs most often in the first 30 days post implant. potential risks include interruption of circulatory support due to a pump stop.The reported complaint rate for this contamination is approximately 5.0% of all units sold; however, the actual occurrence rate of serious injury associated with the failure is approximately 1.06%. the majority of reported injuries were categorised as serious due to prophylactic hospitalisation for the cleaning procedure with or without associated medical intervention.Heartware has implemented manufacturing process improvements to prevent driveline connector contamination in new implant kits.
  • Acción
    HeartWare is advising clincians that patients with implanted devices that experience electrical faults due to driveline connector contamination should see a medium alert on their controller display. In this case, the clinician should contact their HeartWare representative promptly to schedule a driveline connector cleaning procedure by a qualified HeartWare technician, as described in HeartWare Ventricular Assist System Instructions for Use, section 3.24. Do not attempt to repair or service any components of the HeartWare System. For devices that have not been implanted, clinicians are advised to identify affected product with HeartWare, who will provide replacement devices and arrange for the return of the affected product. This action has been closed-out on 04/05/2017.

Device

HeartWare Ventricular Assist Device (HVAD) System HeartWare HVAD Pump Implant Kit
  • Modelo / Serial
    HeartWare Ventricular Assist Device (HVAD) SystemHeartWare HVAD Pump Implant KitModel Number: 1104Serial Number: Serial numbers lower than HW25838ARTG Number: 181875
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA